Vaccines in NICU

1. Vaccines in NICU St. Louis Area Neonatology Conference October 6, 2011 Kelly Burch, Pharm.D. Mercy Children’s Hospital

2. Vaccines in NICU Gateway Pediatric Pharmacy Group July 6, 2011 ACPE 0180-0000-11-043-L01-P Kelly Burch, Pharm.D. Mercy Children’s Hospital

3. Gates Foundation Vaccine Videos http://www.gatesfoundation.org/vaccines/Pages/crying-baby-symphony.aspx http://www.gatesfoundation.org/annual-letter/2011/Pages/videos.aspx

4. What goes in this talk? Cocooning and NICU patients Hepatitis B vaccine in Missouri NICU parent/visitor policies and vaccines Breastfeeding and vaccines Discussing vaccine safety with reluctant parents Organizing 60 day vaccines for NICU patients Acetaminophen prophylaxis Rotavirus vaccine in NICU Nicotine vaccine Passive immunization vs. RSV Instant, reliable vaccine information sources

5. Cocooning • Flu • ACOG recommendation re/ pregnant women • Family immunization • NICU programs • Pharmacies • HCW immunization vs flu • LAIV vs TIV

6. Cocooning… • Pertussis • Tdap vaccine boosts immunity vs. pertussis • at 11 years (or other adolescent visit) • upon indication for tetanus booster (injury, or volunteer work) • 6/22/11 ACIP PG 2nd trimester late or 3rd • OKs: PG, recent Td, 65 years or older • Post partum standing orders for mothers • HCW immunization

7. Hepatitis B vaccine in Missouri Birth dose recommended Why? Birth dose prevents vertical transmission Prenatal screening imperfect Wrong test Transcription error Communication error Negative at time of screening, subsequent infection

8. HepB Dose 1 and LBW infants Review the hepatitis B vaccination recommendations for preterm infants who weigh less than 2kg, as well as for those premature infants who weigh more. Preterm infants weighing less than 2 kg (4.4 lb) at birth have a decreased response to hepatitis B vaccine administered before age 1 month. By age 1 month, medically stable preterm infants, regardless of initial birth weight or gestational age, have an immunologic response to hepatitis B vaccination that is comparable to that of full-term infants. For preterm infants weighing less than 2 kg at birth: • If maternal HBsAg status is positive:HBIG plus hepatitis B vaccine within 12 hours of birth. Give 3 additional hepatitis B vaccine doses (with single-antigen vaccine at ages 1, 2-3, and 6 months, or hepatitis B-containing combination vaccine at ages 2, 4, and 6 months [Pediarix] or 2, 4, and 12-15 months [Comvax]. Test for HBsAg and antibody to HBsAg 1-2 months after completion of at least 3 doses of a licensed hepatitis B vaccine series (i.e., at age 9-18 months, generally at the next well-child visit). Testing should not be performed before age 9 months nor within 4 weeks of the most recent vaccine dose. • If maternal HBsAg status is unknown:Give HBIG plus hepatitis B vaccine within 12 hours of birth. Be sure to test the mother's blood for HBsAg. Give 3 additional hepatitis B vaccine doses (with single-antigen vaccine at ages 1, 2-3, and 6 months, or hepatitis B-containing combination vaccine at ages 2, 4, and 6 months [Pediarix] or 2, 4, and 12-15 months [Comvax]. • If the maternal HBsAg status is negative:If you are certain that appropriate maternal testing was done and a copy of the mother's original laboratory report indicating that she was HBsAgnegative during this pregnancy is placed on the infant's chart, delay the first dose of hepatitis B vaccine until age 1 month or hospital discharge, whichever comes first. Complete the vaccine series per the recommended schedule.For preterm infants weighing 2 kg or more at birth, follow the recommendations for full-term infants including the birth dose for all, keeping in mind the special needs of newborns whose mother's HBsAg status is positive or unknown.

9. Parent/visitor/staff vaccines and NICU Highly recommended: Flu (TIV), pertussis Fine: virtually all others Concerns re/ NICU patients as immunosuppressed: varicella (chicken pox and shingles) Should a healthy person age 60 years or older receive zoster vaccine if they are going to be in contact with an unvaccinated infant or an immunocompromised person? Neither situation is a contraindication to zoster vaccination. A person who gets vaccinated with zoster vaccine who has close household or occupational contact with people who are at risk for developing severe varicella or zoster infection need not take any precautions after receiving zoster vaccine. The only exception is in the rare instance when a person develops a varicella-like rash after receiving zoster vaccine. A vaccine rash is expected to occur less frequently after zoster vaccine is given than after varicella vaccine is given. If a rash develops, the vaccinated person should restrict contact with an IC person if the IC person is susceptible to varicella. After receiving varicella vaccine, should healthcare personnel avoid contact with immunocompromised patients? No. This is not necessary unless the person who was vaccinated develops a rash. Is there any concern when giving varicella vaccine to a child who lives with a susceptible pregnant woman or an IC individual? ACIP recommends varicella vaccine for healthy household contacts of pregnant women and immunosuppressed people. Although there may be a small risk of transmission of varicella vaccine virus to household contacts, the risk is much greater that the susceptible child will be infected with wild-type varicella, which could present a more serious threat to household contacts.

10. Parent/visitor/staff vaccines and NICU Concerns (theoretical): LAIV Can LAIV be given to contacts of immunosuppressed patients? Like other live vaccines, LAIV should not be administered to immunosuppressed persons. ACIP has stated a preference for using inactivated influenza vaccine for household members, healthcare personnel, and others who have close contact with severely immunosuppressed individuals (e.g., patients with hematopoietic stem cell transplants) during those periods in which the immunosuppressed person requires care in a protective environment because of the theoretical risk that the live attenuated vaccine virus could be transmitted to the severely immunosuppressed individual and cause disease. Healthcare personnel or other persons who have close contact with persons with lesser degrees of immunosuppression (e.g., persons with diabetes, persons with asthma taking corticosteroids, or persons infected with human immunodeficiency virus) who are otherwise eligible for LAIV may receive it. No special precautions need to be taken by the vaccinated person

11. Vaccines and breastfeeding Q: Which vaccines can be given to breastfeeding women?A: All vaccines except smallpox can be given to breastfeeding women. Breastfeeding is a precaution for yellow fever vaccine. Women who are breastfeeding should be advised to postpone travel to yellow fever endemic or epidemic regions; however, if travel cannot be postponed the woman should receive yellow fever vaccine. “Ask the experts.” IAC Express 2011 Issue number 922: April 6, 2011

12. 60 day vaccines in NICU • 60 day antigens • Hemophilusinfluenzae type B (HIB) • Hepatitis B • Polio (IPV) • Diphtheria, tetanus, acellularpertussis (DTaP) • Pneumococcus (PCV) • Rotavirus • How many shots? Five? Four? Three? • All at once? Spread out? • Predictable process helps avoid duplications and omissions

13. One way to organize 60 day vaccines in NICU VISs, consents, records Sucrose prior to injections Acetaminophen 15 mg/kg PO prn temp greater than 38.5 x 48 hours Day 1: Prevnar and HIB Day 2: Pediarix (DTaP/IPV/HepB)

14. Acetaminophen prophylaxis Prymula R, Siegrist CA, Chlibek R, Zemlicoova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and AB responses in children: two open label RCTs. Lancet 2009;374:1339. Acetaminophen 15 mg/kg x 1 PO prior to immunization, and q 6 hours x 4 after pertussis vaccine. Attenuated antibody response after vaccine with acetaminophen px; no difference in adverse outcomes after vaccine. Removal of recommendation from 2010 ACIP and AAP. Acetaminophen prn-fever, irritability.

15. Short intervals and catch up schedules in NICU • Dose 1 of primary series may be given at 6 weeks of age • Minimum interval between dose 1 and dose 2 may be four weeks. • Multiparity • Long stay NICU • Social chaos • Multiples who wish same schedule • Winter

16. Rotavirus vaccine in NICU • Concern re/ vaccine virus transmission • 10% of vaccinees excrete vaccine virus in stool • Some NICU infants are immunosuppressed. • Options • Do not immunize NICU infants vs. rotavirus • Defer rotavirus immunization until day of discharge • Immunize on time with no special considerations

17. Rapid screening for quality in NICU immunization • Sort patient list by birthdate. • Check all over 2 months old for: • Vaccines administered or • Contraindication • Valid contraindications • Recent glucocorticoid therapy (possible attenuated response) • Small size (presumed small thighs) • Invalid contraindication • Wish to avoid noxious stimulus (provide analgesia) • Parents don’t visit (phone contact/VISs by alternate means) • Parents refuse

18. Counseling the reluctant parent Don’t need vaccines, against diseases nobody gets anymore. Also, isn’t it better to get natural immunity? Practice in 1930s-40s… diphtheria or pertussis Practice in 50s…polio Practice in 60s…measles Practice in 80s…Hib disease Practice in 90s …pneumococcal meningitis, or varicella Practice in 00s …rotavirus

19. We’ll hide in the herd. Won’t work for everyone. If everyone in your social group avoids vaccines, you are at special risk. Citizenship. Counseling the reluctant parent

20. Vaccines cause autism Thimerosol causes autism because of mercury poisoining. Careful studies in England, USA, and Europe do not show any association between vaccines and autism. Thimerosol has been gone from vaccines since 1998…still have increasing number of children with autism. Persistent ideas about vaccines and autism

21. Communication techniques for vaccine counseling: Making the CASE. Corroborate-acknowledge concern and find some point on which you can agree About me…describe what you have done to improve your knowledge and expertise Science…describe what the science says Explain/advise…based on the science

22. CASE practice: I heard on TV that vaccines cause autism Corroborate: There’s certainly been a lot of coverage on television about vaccines and autism so I can understand why you have questions… About Me: I always want to make sure I’m up to date on the latest information so that I can do what’s best for my patients, so I’ve researched this thoroughly. In fact, I just went to pediatric pharmacists meeting…. Science: The scientific evidence does not support a causal link. The CDC, the AAP, the NIH, the IOM (etc) all reviewed the data and all reached the same conclusion. Dozens of studies have been done. None show a link. In fact, the latest autism science indicates that autism symptoms are present in young infants, before any vaccines are given… Explain/Advise: Vaccines are critical to maintaining health and wellbeing. They prevent diseases that cause real harm. Choosing not to vaccinate does not protect children from autism, but does leave them open to diseases. Kids need these vaccines….

23. CASE practice: What is so bad about measles? I had chicken pox and I was fine. Corroborate: I can understand why you might feel that way. I had it too. About Me: The vaccine program has been so successful and a lot of the diseases that we feared, like polio, are no longer a concern. Until last year, I had never seen a case of HIB or measles, but now these diseases are making a comeback. My colleague in San Diego was telling me about what’s going on in CA regarding the whooping cough epidemic. In my practice….. Science: Bad diseases have come back in areas where vaccination rates are low. Last year, 5 children died of HIB. 9 California babies died this year of pertussis. If you want to see a video that would break your heart, watch a coughing fit from pertussis, and imagine a former premature baby dealing with that. Explain: We care about our patients and don’t want to practice substandard care. All our patients need to be vaccinated. My children are vaccinated.

24. CASE practice: I want to spread out the shots. Overwhelming to a little baby. Corroborate: Kids today certainly get more shots than kids did yearsago. About Me: We follow the CDC schedule because it iscarefully designed to protect children at the time they are mostvulnerable to each disease. I recently returned from a meeting, or I served on a committee that reviewed the schedule… Science: Although kids get more shots today, they actually receivefewer antigens than when they got fewer shots, because technologyhas enabled us to make vaccines that have only the part of the cellthat induces immune response. Plus, the immunological challengefrom a vaccine is nothing compared to what kids fight off every day.An ear infection is a bigger immunological challenge. “Drop in theocean” Explain: We want all the kids in our practice to be immunized so thatthey have the greatest chance for a long, healthy life. My own children are fully immunized.

25. Sources of information for parents Freed GL. Sources and perceived credibility of vaccine safety information for parents. Pediatrics 2011;127 suppl 1: S107.

26. Sources of information for parents Freed GL. Sources and perceived credibility of vaccine safety information for parents. Pediatrics 2011;127 suppl 1: S107.

27. Nicotine vaccine

28. Nicotine vaccine • Stimulates anti-N antibody, complexes with N, complex too large to cross BBB (or placenta) • Three different vaccines, closest to approval is 3’-AmNic-rEPA (Nabi Pharm, NicVAX) • Phase II trials reveal AB persistence x 6 months. 30 day quit rates of 38% vs 9%. • Phase III trials in progress; 400 mcg monthly x 6; AB levels, quit at 6 and 12 months, weight gain, adversities Hatsukani DK, Rennard S, Jorenby D, et al. Safety and immunogenicity of a nicotine conjugate vaccine in current smokers. Clin Pharmacol Ther 2005;78:456-7.

29. Nicotine vaccine • Combination therapy (bupropion, varenicline, behavioral therapy) • Primary prevention • Pregnancy Ottney AR. Nicotine conjugate vaccine as a novel approach to smoking cessation. Pharmacotherapy 2011;31:703-13.

30. Passive immunization against RSV Changing criteria and risk factor assessment Patient identification • Summer born • Season born Using V coding/clinical database problem list Using inpatient Rx for follow up Pediatrician notification Power of parents

31. Information on vaccines…for families • www.vaccineinformation.org • Parents’ PACK (CHOP Vaccine Education Center) http://www.chop.edu/service/parents-possessing-accessing-communicating-knowledge-about-vaccines/home.html • Every Child by Two: www.ecbt.org • Families Fighting Flu: www.familiesfightingflu.org

32. Information on vaccines…for professionals • Websites www.immunize.org www.cdc.gov/vaccines or www.vaccines.gov Vaccine Education Center at CHOP: www.vaccine.chop.edu • Newsletters (e and paper) IAC Express Vaccinate Children! Vaccinate Adults! CHOP Vaccine Education Center • Books Do Vaccines Cause That? A Guide for Evaluating Vaccine Safety Concerns Myers MG, Pineda D 2008 Deadly ChoicesOffit 2011

33. Gates Foundation Vaccine Videos http://www.gatesfoundation.org/vaccines/Pages/crying-baby-symphony.aspx http://www.gatesfoundation.org/annual-letter/2011/Pages/videos.aspx